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NCT Number: NCT05649852

Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy

The purpose of the study is to assess the average of the "State Anxiety" score of the State Trait Inventory Anxiety at the end of the third cycle of chemotherapy compared to the pre-treatment score (inclusion)

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé Drôme Ardèche

Valence, 26000, France

Location status: Recruiting

Location contact

Louis DOUBLET, MD

CONTACT

[email protected]

4 75 75 87 93 ext. +33

About this study

As part of this study, patients will be seen 6 times for the purposes of the study: on inclusion, during the first four courses of chemotherapy and at the end of chemotherapy.

The study is offered to the patient during the consultation with the oncologist before the start of chemotherapy. It may possibly be proposed at the latest when he enters hospitalization for chemotherapy.

Two cohorts of patients will be included:

  • Patients treated with chemotherapy every 21 days for lung, breast, digestive, colorectal or gynecological cancer;
  • Patients treated with chemotherapy every 14 days for digestive or other cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with cancer treated with adjuvant chemotherapy with an interval of 14 or 21 days for the first 3 cycles;
  • Chemotherapy naïve patient;
  • Patient speaking and understanding French and able to complete the questionnaires;
  • Patient having been informed and having signed an informed consent form to participate in the study.

Exclusion criteria

  • Patient who has already benefited from socio-aesthetic care;
  • Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
  • Patient unable to understand the information related to the study (linguistic, psychological, cognitive reasons, etc.);
  • Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;
  • Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
  • Patient not benefiting from a social security scheme.

Treatment and study plan

Socio-aesthetic care

Other

Group A (Socio-aesthetic care): 3 sessions carried out by a socio-esthetician, during the first administration of chemotherapy.

Supportive Care

Other

Group B (control) will not benefit of socio-aesthetic care during chemotherapy but will benefit all existing support care in the center and accessible to patients: psychology consultation, sophrology, art therapy, physiotherapy, hypnosis. The patient will receive support care (maximum 2) during the intercure.

Primary outcomes

  1. Change of mean of the "State Anxiety" score of the State Trait Inventory Anxiety

    Time frame: Between the inclusion and the end of the third cycle of chemotherapy (maximum cycle of 21 days)

    Change of mean of the "State Anxiety" score of the State Trait Inventory Anxiety at the end of the third cycle of chemotherapy compared to the pre-treatment score (inclusion)

Study contacts

Contact information is provided by the study sponsor or research team.

Louis DOUBLET, MD

CONTACT

[email protected]

4 75 75 87 93 ext. +33

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • Euraxi Pharma

Registry information

Official study title

Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy (PASITHEA)

Acronym: PASITHEA

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 14, 2022
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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